Controlling medical infusion device operation and features based on detected patient sleeping status

ABSTRACT

A method of operating an insulin infusion device involves: operating the infusion device in an automatic mode to automatically control delivery of insulin to a user, in accordance with a first target glucose setpoint value; receiving user status data that indicates sleeping status of the user, the user status data generated by a sleep detection system; and determining, from the user status data, that the user is sleeping while the insulin infusion device is operating in the automatic mode. In response to the determining, the method transitions from the first target glucose setpoint value to a second (different) target glucose setpoint value for use during the automatic mode, the transitioning occurring without user input. The method continues to operate the infusion device in the automatic mode to automatically control delivery of insulin to the user, in accordance with the second target glucose setpoint value.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. provisional patentapplication No. 62/947,942, filed Dec. 13, 2019. This application alsoclaims the benefit of U.S. provisional patent application No.62/893,722, filed Aug. 29, 2019.

TECHNICAL FIELD

The present technology is generally related to the control of medicaldevice operation and features, such as alert generation and regulationof therapy delivery.

BACKGROUND

Medical therapy delivery systems, such as fluid infusion devices, arerelatively well known in the medical arts, for use in delivering ordispensing an agent, such as insulin or another prescribed medication,to a patient. A typical insulin infusion device includes a fluid pumpmechanism and an associated drive system that actuates a plunger orpiston of a fluid reservoir to deliver fluid medication from thereservoir to the body of a patient via a fluid delivery conduit betweenthe reservoir and the body of a patient. Use of infusion pump therapyhas been increasing, especially for delivering insulin to diabeticpatients.

Medical devices, including insulin infusion devices, can be controlledand operated to generate and output (or control the generation andoutputting) of various alerts, alarms, messages, and notifications, indifferent contexts and for different reasons. Some alerts may be merelyinformative in nature, while other alerts may be more important. Forexample, alerts related to patient safety, operating health of themedical device, and patient health status may be categorized as highpriority, while alerts related to battery charge status, patientreminders or recommendations, and non-critical device status may becategorized as low priority.

Control schemes have been developed to allow insulin infusion devices tomonitor and regulate a patient's blood glucose level in a substantiallycontinuous and autonomous manner. An insulin infusion device can beoperated in an automatic mode wherein basal insulin is delivered at arate that is automatically adjusted for the user. While controlling thedelivery of basal insulin in this manner, the infusion device can alsocontrol the delivery of correction boluses to account for rising glucosetrends, a sudden spike or drop in detected blood glucose, etc. Ideally,the amount of a correction bolus should be accurately calculated andadministered to maintain the user's blood glucose within the desiredrange. In particular, an automatically generated and deliveredcorrection bolus should safely manage the user's blood glucose level andkeep it above a defined threshold level. To this end, an insulininfusion device operating in an automatic mode uses continuous glucosesensor data and control algorithms to regulate the user's blood glucose,based on a target glucose setpoint setting.

BRIEF SUMMARY

The subject matter of this disclosure generally relates to theregulation and control of certain features and functions of a medicaldevice, such as an insulin infusion device, based on the output of asleep detection system that monitors the sleeping status of the patient.The disclosed subject matter contemplates the adjustment of a medicaldevice alerting scheme in response to the detected or determinedsleeping status of the patient. The disclosed subject matter alsocontemplates the adjustment of a target glucose setpoint value of aninsulin infusion device, in response to the detected or determinedsleeping status of the patient.

In one aspect, the present disclosure provides an automated method ofcontrolling alerts associated with operation of a medical device.Embodiments of the method involve: receiving user status data thatindicates sleeping status of a user of the medical device, the userstatus data generated by a sleep detection system; determining, from theuser status data, that the user is sleeping; in response to thedetermining, activating a sleep mode alerting scheme of the medicaldevice; and after activating the sleep mode alerting scheme, controllinggeneration and outputting of alerts associated with operation of themedical device in accordance with the sleep mode alerting scheme.

In another aspect, the disclosure provides a medical device thatregulates delivery of medication to a user. Embodiments of the medicaldevice include: a fluid pump mechanism; at least one controller thatregulates operation of the fluid pump mechanism to deliver a fluidmedication from the medical device; and at least one memory elementassociated with the at least one controller. The at least one memoryelement stores processor-executable instructions configurable to beexecuted by the at least one controller to perform a method ofcontrolling operation of the medical device. Embodiments of the methodinvolve: receiving user status data that indicates sleeping status ofthe user, the user status data generated by a sleep detection system;determining, from the user status data, that the user is sleeping; inresponse to the determining, activating a sleep mode alerting scheme ofthe medical device; and after activating the sleep mode alerting scheme,controlling generation and outputting of alerts associated withoperation of the medical device in accordance with the sleep modealerting scheme.

In another aspect, the disclosure provides a system having: a medicaldevice that regulates delivery of medication to a user; a sleepdetection system configured to generate user status data that indicatessleeping status of the user, and configured to communicate the userstatus data; and at least one controller that controls alerts associatedwith operation of the medical device. The at least one controller isconfigured to: receive the user status data generated by the sleepdetection system; determine, from the user status data, that the user issleeping; in response to determining that the user is sleeping,activating a sleep mode alerting scheme of the medical device; and afteractivating the sleep mode alerting scheme, control generation andoutputting of alerts associated with operation of the medical device inaccordance with the sleep mode alerting scheme.

In another aspect, the disclosure provides a method of operating aninsulin infusion device having a fluid pump mechanism and at least onecontroller that regulates operation of the fluid pump mechanism todeliver insulin from the insulin infusion device. Embodiments of themethod involve: operating the insulin infusion device in an automaticmode to automatically control delivery of insulin to a user, inaccordance with a first target glucose setpoint value; receiving userstatus data that indicates sleeping status of the user, the user statusdata generated by a sleep detection system; determining, from the userstatus data, that the user is sleeping while the insulin infusion deviceis operating in the automatic mode; in response to the determining,transitioning from the first target glucose setpoint value to a secondtarget glucose setpoint value for use during the automatic mode, thetransitioning occurring without user input, and the second targetglucose setpoint value different than the first target glucose setpointvalue; and continuing to operate the insulin infusion device in theautomatic mode to automatically control delivery of insulin to the user,in accordance with the second target glucose setpoint value.

In another aspect, the disclosure provides an insulin infusion devicehaving: a fluid pump mechanism; at least one controller that regulatesoperation of the fluid pump mechanism to deliver insulin from theinsulin infusion device; and at least one memory element associated withthe at least one controller, the at least one memory element storingprocessor-executable instructions configurable to be executed by the atleast one controller to perform a method of controlling operation of theinsulin infusion device. Embodiments of the method involve: operatingthe insulin infusion device in an automatic mode to automaticallycontrol delivery of insulin to a user, in accordance with a first targetglucose setpoint value; receiving user status data that indicatessleeping status of the user, the user status data generated by a sleepdetection system; determining, from the user status data, that the useris sleeping while the insulin infusion device is operating in theautomatic mode; in response to the determining, transitioning from thefirst target glucose setpoint value to a second target glucose setpointvalue for use during the automatic mode, the transitioning occurringwithout user input, and the second target glucose setpoint valuedifferent than the first target glucose setpoint value; and continuingto operate the insulin infusion device in the automatic mode toautomatically control delivery of insulin to the user, in accordancewith the second target glucose setpoint value.

In another aspect, the disclosure provides a system having: an insulininfusion device that regulates delivery of insulin to a user; a sleepdetection system configured to generate user status data that indicatessleeping status of a user, and configured to communicate the user statusdata; and at least one controller that controls operation of the insulininfusion device. The at least one controller is configured to: operatethe insulin infusion device in an automatic mode to automaticallycontrol delivery of insulin to a user, in accordance with a first targetglucose setpoint value; receive the user status data generated by thesleep detection system; determine, from the user status data, that theuser is sleeping while the insulin infusion device is operating in theautomatic mode; in response to determining that the user is sleeping,transition from the first target glucose setpoint value to a secondtarget glucose setpoint value for use during the automatic mode, thetransitioning occurring without user input, and the second targetglucose setpoint value different than the first target glucose setpointvalue; and continue to operate the insulin infusion device in theautomatic mode to automatically control delivery of insulin to the user,in accordance with the second target glucose setpoint value.

The details of one or more aspects of the disclosure are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the techniques described in this disclosurewill be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a simplified block diagram representation of an exemplaryembodiment of a system that includes a medical device and a sleepdetection system;

FIG. 2 is a block diagram representation of an exemplary embodiment of acomputer-based or processor-based device suitable for deployment in thesystem shown in FIG. 1;

FIG. 3 is a block diagram representation of a closed loop glucosecontrol system arranged in accordance with certain embodiments;

FIG. 4 is a block diagram representation of a sleep detection systemarranged in accordance with certain embodiments;

FIG. 5 is a flow chart that illustrates an alert control processaccording to certain embodiments;

FIG. 6 is a flow chart that illustrates an alert annunciation/outputcontrol process according to certain embodiments; and

FIG. 7 is a flow chart that illustrates an insulin infusion devicecontrol process according to certain embodiments.

DETAILED DESCRIPTION

The following detailed description is merely illustrative in nature andis not intended to limit the embodiments of the subject matter or theapplication and uses of such embodiments. As used herein, the word“exemplary” means “serving as an example, instance, or illustration.”Any implementation described herein as exemplary is not necessarily tobe construed as preferred or advantageous over other implementations.Furthermore, there is no intention to be bound by any expressed orimplied theory presented in the preceding technical field, background,brief summary or the following detailed description.

It should be understood that various aspects disclosed herein may becombined in different combinations than the combinations specificallypresented in the description and accompanying drawings. It should alsobe understood that, depending on the example, certain acts or events ofany of the processes or methods described herein may be performed in adifferent sequence, may be added, merged, or left out altogether (e.g.,all described acts or events may not be necessary to carry out thetechniques). In addition, while certain aspects of this disclosure aredescribed as being performed by a single module or unit for purposes ofclarity, it should be understood that the techniques of this disclosuremay be performed by a combination of units or modules associated with,for example, a medical device.

In one or more examples, the described techniques may be implemented inhardware, software, firmware, or any combination thereof If implementedin software, the functions may be stored as one or more instructions orcode on a computer-readable medium and executed by a hardware-basedprocessing unit. Computer-readable media may include non-transitorycomputer-readable media, which corresponds to a tangible medium such asdata storage media (e.g., RAM, ROM, EEPROM, flash memory, or any othermedium that can be used to store desired program code in the form ofinstructions or data structures and that can be accessed by a computer).

Instructions may be configurable to be executed by one or moreprocessors, such as one or more digital signal processors (DSPs),general purpose microprocessors, application specific integratedcircuits (ASICs), field programmable logic arrays (FPGAs), or otherequivalent integrated or discrete logic circuitry. Accordingly, the term“processor” as used herein may refer to any of the foregoing structureor any other physical structure suitable for implementation of thedescribed techniques. Also, the techniques could be fully implemented inone or more circuits or logic elements.

Techniques and technologies may be described herein in terms offunctional and/or logical block components, and with reference tosymbolic representations of operations, processing tasks, and functionsthat may be performed by various computing components or devices. Suchoperations, tasks, and functions are sometimes referred to as beingcomputer-executed, computerized, software-implemented, orcomputer-implemented. It should be appreciated that the various blockcomponents shown in the figures may be realized by any number ofhardware, software, and/or firmware components configured to perform thespecified functions. For example, an embodiment of a system or acomponent may employ various integrated circuit components, e.g., memoryelements, digital signal processing elements, logic elements, look-uptables, or the like, which may carry out a variety of functions underthe control of one or more microprocessors or other control devices.

Turning now to FIG. 1, exemplary embodiments of a system 100 include,without limitation: a medical device 102 that regulates delivery ofmedication to a user; and a sleep detection system 104 configured togenerate user status data that indicates sleeping status of the user.The medical device 102 and the sleep detection system 104 are owned by,operated by, or otherwise associated with a user/patient. The output ofthe sleep detection system 104 can be used to influence features,functions, and/or therapy-related operations of the medical device 102.Certain embodiments of the system 100 may include any or all of thefollowing, without limitation: an analyte sensor 106 to measure aphysiological characteristic of the user, such that sensor data obtainedfrom the analyte sensor 106 can be used to control, regulate, orotherwise influence the operation of the medical device 102; anancillary control system 108 configured to remotely control at leastsome features, functions, or operations of the medical device 102 viasuitably formatted commands, instructions, or control signals; and anancillary alerting device 110 configured to generate alerts, alarms,messages, and/or notifications associated with the operation of themedical device 102. Additionally or alternatively, the ancillaryalerting device 110 is configured to remotely control or regulate thegeneration or outputting/annunciation of such alerts, alarms, messages,and/or notifications by a component of the system 100 (e.g., the medicaldevice 102 or another device that is capable of displaying, presenting,playing, transmitting, or otherwise outputting such alerts, alarms,message, and/or notifications). Other configurations and topologies forthe system 100 are also contemplated here, such as a system thatincludes additional intermediary, interface, or data repeating devicesin the data path between a sending device and a receiving device.

At least some of the components of the system 100 are communicativelycoupled with one another to support data communication, signaling,and/or transmission of control commands as needed, via at least onecommunications network 112. The at least one communications network 112may support wireless data communication and/or data communication usingtangible data communication links. FIG. 1 depicts network communicationlinks in a simplified manner. In practice, the system 100 may cooperatewith and leverage any number of wireless and any number of wired datacommunication networks maintained or operated by various entities andproviders. Accordingly, communication between the various components ofthe system 100 may involve multiple network links and different datacommunication protocols. In this regard, the network can include orcooperate with any of the following, without limitation: a local areanetwork; a wide area network; the Internet; a personal area network; anear-field data communication link; a cellular communication network; asatellite communication network; a video services or televisionbroadcasting network; a network onboard a vehicle; or the like. Thecomponents of the system 100 may be suitably configured to support avariety of wireless and wired data communication protocols,technologies, and techniques as needed for compatibility with the atleast one communication network 112.

The analyte sensor 106 may communicate sensor data to the medical device102 for use in regulating or controlling operation of the medical device102. Alternatively or additionally, the analyte sensor 106 maycommunicate sensor data to one or more other components in the system100. The sleep detection system 104 may communicate user status data(that indicates sleeping status of the user) directly to the medicaldevice 102, which receives and processes the user status data in anappropriate manner for use in regulating or controlling certainfunctions of the medical device 102. Alternatively or additionally, thesleep detection system 104 may communicate user status data to theancillary control system 108, such that the ancillary control system 108can remotely regulate or control certain functions of the medical device102. For example, the ancillary control system 108 can be configured toremotely control operation of the medical device in response to outputprovided by the sleep detection system 104. Alternatively oradditionally, the sleep detection system 104 may communicate user statusdata to the ancillary alerting device 110 for use in regulating orcontrolling alerts generated by the ancillary alerting device 110 (wherethe alerts are related to or associated with the operation of themedical device, the analyte sensor 106, etc.). As mentioned previously,the ancillary control system 108 may communicate control signals,commands, or instructions to the medical device 102, to the ancillaryalerting device 110, and/or other components of the system 100 toregulate or control settings, features, functions, and/or operations ofthose components.

In certain embodiments, the sleep detection system 104 and the medicaldevice 102 are implemented as physically distinct and separatecomponents, as depicted in FIG. 1. In such embodiments, the sleepdetection system 104 is external to the medical device 102 and isrealized as an ancillary component, relative to the medical device 102.In accordance with alternative embodiments, however, the medical device102 and the sleep detection system 104 can be combined into a singlehardware component or provided as a set of attached hardware devices.For example, the medical device 102 may include the sleep detectionsystem 104 or integrate the functionality of the sleep detection system104. Similarly, the ancillary control system 108 can be incorporatedwith the sleep detection system 104 or the ancillary alerting device 110in some embodiments. Similarly, the ancillary alerting device 110 can beincorporated with the sleep detection system 104 in certain embodiments.These and other arrangements, deployments, and topologies of the system100 are contemplated by this disclosure.

As described in more detail below, the sleep detection system 104detects or determines whether the user is awake or sleeping. The sleepdetection system 104 may also determine other sleep-relatedcharacteristics, such as the sleep onset time, the waking time, theduration of sleep, a quality metric or measurement that indicates howwell the user slept, etc. The sleep detection system 104 generates andcommunicates user status data (that indicates the sleeping status of theuser) to a destination device of the system 100, e.g., the medicaldevice 102. In response to the sleeping status of the user, certainfunctions, settings, and/or operations of the medical device 102 can beregulated, controlled, or adjusted in an appropriate manner. In certainembodiments, a sleep mode alerting scheme of the medical device 102 isactivated when the user is sleeping. The sleep mode alerting schemeregulates the generation, timing, prioritization, and/or output type ofalerts associated with operation of the medical device 102. Inaccordance with certain embodiments where the medical device 102 is aninsulin infusion device, a target glucose setpoint value is adjusted(e.g., lowered) when the sleep detection system 104 determines that theuser is sleeping. The lowered target glucose setpoint value is utilizedduring an automatic insulin delivery mode while the user remains asleep.

In accordance with certain embodiments, any or all of the componentsshown in FIG. 1 can be implemented as a computer-based or aprocessor-based device, system, or component having suitably configuredhardware and software written to perform the functions and methodsneeded to support the features described herein. In this regard, FIG. 2is a simplified block diagram representation of an exemplary embodimentof a computer-based or processor-based device 200 that is suitable fordeployment in the system 100 shown in FIG. 1.

The illustrated embodiment of the device 200 is intended to be ahigh-level and generic representation of one suitable platform. In thisregard, any computer-based or processor-based component of the system100 can utilize the architecture of the device 200. The illustratedembodiment of the device 200 generally includes, without limitation: atleast one controller (or processor) 202; a suitable amount of memory 204that is associated with the at least one controller 202; device-specificitems 206 (including, without limitation: hardware, software, firmware,user interface (UI), alerting, and notification features); a powersupply 208 such as a disposable or rechargeable battery; a communicationmodule 210; and a display element 212. Of course, an implementation ofthe device 200 may include additional elements, components, modules, andfunctionality configured to support various features that are unrelatedto the primary subject matter described here. For example, the device200 may include certain features and elements to support conventionalfunctions that might be related to the particular implementation anddeployment of the device 200 (e.g., haptic technology). In practice, theelements of the device 200 may be coupled together via at least one busor any suitable interconnection architecture 214.

The at least one controller 202 may be implemented or performed with ageneral purpose processor, a content addressable memory, amicrocontroller unit, a digital signal processor, an applicationspecific integrated circuit, a field programmable gate array, anysuitable programmable logic device, discrete gate or transistor logic,discrete hardware components, or any combination designed to perform thefunctions described here. Moreover, the at least one controller 202 maybe implemented as a combination of computing devices, e.g., acombination of a digital signal processor and a microprocessor, aplurality of microprocessors, one or more microprocessors in conjunctionwith a digital signal processor core, or any other such configuration.

The memory 204 may be realized as at least one memory element, device,module, or unit, such as: RAM memory, flash memory, EPROM memory, EEPROMmemory, registers, a hard disk, a removable disk, a CD-ROM, or any otherform of storage medium known in the art. In this regard, the memory 204can be coupled to the at least one controller 202 such that the at leastone controller 202 can read information from, and write information to,the memory 204. In the alternative, the memory 204 may be integral tothe at least one controller 202. As an example, the at least onecontroller 202 and the memory 204 may reside in an ASIC. At least aportion of the memory 204 can be realized as a computer storage mediumthat is operatively associated with the at least one controller 202,e.g., a tangible, non-transitory computer-readable medium havingcomputer-executable instructions stored thereon. The computer-executableinstructions are configurable to be executed by the at least onecontroller 202 to cause the at least one controller 202 to performcertain tasks, operations, functions, and processes that are specific tothe particular embodiment. In this regard, the memory 204 may representone suitable implementation of such computer-readable media.Alternatively or additionally, the device 200 could receive andcooperate with computer-readable media (not separately shown) that isrealized as a portable or mobile component or platform, e.g., a portablehard drive, a USB flash drive, an optical disc, or the like.

The device-specific items 206 may vary from one embodiment of the device200 to another. For example, the device-specific items 206 will support:sensor device operations when the device 200 is realized as a sensordevice; smartphone features and functionality when the device 200 isrealized as a smartphone; activity tracker features and functionalitywhen the device 200 is realized as an activity tracker; smart watchfeatures and functionality when the device 200 is realized as a smartwatch; medical device features and functionality when the device isrealized as a medical device; etc. In practice, certain portions oraspects of the device-specific items 206 may be implemented in one ormore of the other blocks depicted in FIG. 2.

If present, the UI of the device 200 may include or cooperate withvarious features to allow a user to interact with the device 200.Accordingly, the UI may include various human-to-machine interfaces,e.g., a keypad, keys, a keyboard, buttons, switches, knobs, a touchpad,a joystick, a pointing device, a virtual writing tablet, a touch screen,a microphone, or any device, component, or function that enables theuser to select options, input information, or otherwise control theoperation of the device 200. The UI may include one or more graphicaluser interface (GUI) control elements that enable a user to manipulateor otherwise interact with an application via the display element 212.The display element 212 and/or the device-specific items 206 may beutilized to generate, present, render, output, and/or annunciate alerts,alarms, messages, or notifications that are associated with operation ofthe medical device 102, associated with a status or condition of theuser, associated with operation, status, or condition of the system 100,etc.

The communication module 210 facilitates data communication between thedevice 200 and other components as needed during the operation of thedevice 200. In the context of this description, the communication module210 can be employed to transmit or stream device-related control data,patient-related user status (e.g., sleeping status data), device-relatedstatus or operational data, sensor data, calibration data, and the like.It should be appreciated that the particular configuration andfunctionality of the communication module 210 can vary depending on thehardware platform and specific implementation of the device 200. Inpractice, an embodiment of the device 200 may support wireless datacommunication and/or wired data communication, using various datacommunication protocols. For example, the communication module 210 couldsupport one or more wireless data communication protocols, techniques,or methodologies, including, without limitation: RF; IrDA (infrared);Bluetooth; BLE; ZigBee (and other variants of the IEEE 802.15 protocol);IEEE 802.11 (any variation); IEEE 802.16 (WiMAX or any other variation);Direct Sequence Spread Spectrum; Frequency Hopping Spread Spectrum;cellular/wireless/cordless telecommunication protocols; wireless homenetwork communication protocols; paging network protocols; magneticinduction; satellite data communication protocols; wireless hospital orhealth care facility network protocols such as those operating in theWMTS bands; GPRS; and proprietary wireless data communication protocolssuch as variants of Wireless USB. Moreover, the communication module 210could support one or more wired/cabled data communication protocols,including, without limitation: Ethernet; powerline; home networkcommunication protocols; USB; IEEE 1394 (Firewire); hospital networkcommunication protocols; and proprietary data communication protocols.

The display element 212 is suitably configured to enable the device 200to render and display various screens, recommendation messages, alerts,alarms, notifications, GUIs, GUI control elements, drop down menus,auto-fill fields, text entry fields, message fields, or the like. Ofcourse, the display element 212 may also be utilized for the display ofother information during the operation of the device 200, as is wellunderstood. Notably, the specific configuration, operatingcharacteristics, size, resolution, and functionality of the displayelement 212 can vary depending upon the implementation of the device200.

As shown in FIG. 1, the system 100 can support any type of medicaldevice 102 that is compatible with the features and functionalitydescribed here. In certain embodiments, however, the medical device 102includes or is realized as an insulin infusion device, e.g., a portablepatient-worn or patient-carried insulin pump. For the sake of brevity,conventional techniques related to insulin infusion device operation,infusion set operation, and other functional aspects of the systems (andthe individual operating components of the systems) may not be describedin detail here. Examples of infusion pumps may be of the type describedin, but not limited to, U.S. Pat. Nos.: 4,562,751; 4,685,903; 5,080,653;5,505,709; 5,097,122; 6,485,465; 6,554,798; 6,558,320; 6,558,351;6,641,533; 6,659,980; 6,752,787; 6,817,990; 6,932,584; and 7,621,893;each of which are herein incorporated by reference.

Generally, a fluid infusion device includes a fluid pump mechanismhaving a motor or other actuation arrangement that is operable tolinearly displace a plunger (or stopper) of a fluid reservoir providedwithin the fluid infusion device to deliver a dosage of fluidmedication, such as insulin, to the body of a user. Dosage commands thatgovern operation of the motor may be generated in an automated manner inaccordance with the delivery control scheme associated with a particularoperating mode, and the dosage commands may be generated in a mannerthat is influenced by a current (or most recent) measurement of aphysiological condition in the body of the user. For a glucose controlsystem suitable for use by diabetic patients, a closed-loop or automaticoperating mode can be used to generate insulin dosage commands based ona difference between a current (or most recent) measurement of theinterstitial fluid glucose level in the body of the user and a target(or reference) glucose setpoint value. In this regard, the rate ofinfusion may vary as the difference between a current measurement valueand the target measurement value fluctuates. For purposes ofexplanation, the subject matter is described herein in the context ofthe infused fluid being insulin for regulating a glucose level of a user(or patient); however, it should be appreciated that many other fluidsmay be administered through infusion, and the subject matter describedherein is not necessarily limited to use with insulin.

As mentioned above, the medical device 102 is suitably configured andprogrammed to support an automatic mode to automatically controldelivery of insulin to the user. In this regard, FIG. 3 is a simplifiedblock diagram representation of a closed loop glucose control system 300arranged in accordance with certain embodiments. The system 300 depictedin FIG. 3 functions to regulate the rate of fluid infusion into a bodyof a user based on feedback from an analyte concentration measurementtaken from the body. In particular embodiments, the system 300 isimplemented as an automated control system for regulating the rate ofinsulin infusion into the body of a user based on a glucoseconcentration measurement taken from the body. The system 300 isdesigned to model the physiological response of the user to control aninsulin infusion device 302 in an appropriate manner to release insulin304 into the body 306 of the user in a similar concentration profile aswould be created by fully functioning human (3-cells when responding tochanges in blood glucose concentrations in the body. Thus, the system300 simulates the body's natural insulin response to blood glucoselevels and not only makes efficient use of insulin, but also accountsfor other bodily functions as well since insulin has both metabolic andmitogenic effects.

Certain embodiments of the system 300 include, without limitation: theinsulin infusion device 302; a glucose sensor system 308 (e.g., theanalyte sensor 106 shown in FIG. 1); and at least one controller 310,which may be incorporated in the insulin infusion device 302 as shown inFIG. 3. The glucose sensor system 308 generates a sensor signal 314representative of blood glucose levels 316 in the body 306, and providesthe sensor signal 314 to the at least one controller 310. The at leastone controller 310 receives the sensor signal 314 and generates commands320 that regulate the timing and dosage of insulin 304 delivered by theinsulin infusion device 302. The commands 320 are generated in responseto various factors, variables, settings, and control algorithms utilizedby the insulin infusion device 302. For example, the commands 320 (and,therefore, the delivery of insulin 304) can be influenced by a variabletarget glucose setpoint value 322 that is maintained and regulated bythe insulin infusion device 302. As described in more detail below, thetarget glucose setpoint value 322 can be lowered when the system 100(see FIG. 1) determines that the user is asleep, and can be raised whenthe system 100 determines that the user is no longer asleep.

Generally, the glucose sensor system 308 includes a continuous glucosesensor, sensor electrical components to provide power to the sensor andgenerate the sensor signal 314, a sensor communication system to carrythe sensor signal 314 to the at least one controller 310, and a sensorsystem housing for the electrical components and the sensorcommunication system. As mentioned above with reference to FIG. 2, theglucose sensor system 308 may be implemented as a computer-based orprocessor-based component having the described configuration andfeatures.

Typically, the at least one controller 310 includes controllerelectrical components and software to generate commands for the insulininfusion device 302 based on the sensor signal 314, the target glucosesetpoint value 322, and other user-specific parameters, settings, andfactors. The at least one controller 310 may include a controllercommunication system to receive the sensor signal 314 and issue thecommands 320.

Generally, the insulin infusion device 302 includes a fluid pumpmechanism 328, a fluid reservoir 330 for the medication (e.g., insulin),and an infusion tube 332 to infuse the insulin 304 into the body 306. Incertain embodiments, the insulin infusion device 302 includes aninfusion communication system to handle the commands 320 from the atleast one controller 310, electrical components and programmed logic toactivate the fluid pump mechanism 328 motor according to the commands320, and a housing to hold the components of the insulin infusion device302. Accordingly, the fluid pump mechanism 328 receives the commands 320and delivers the insulin 304 from the fluid reservoir 330 to the body306 in accordance with the commands 320. It should be appreciated thatan embodiment of the insulin infusion device 302 can include additionalelements, components, and features that may provide conventionalfunctionality that need not be described herein. Moreover, an embodimentof the insulin infusion device 302 can include alternative elements,components, and features if so desired, as long as the intended anddescribed functionality remains in place. In this regard, as mentionedabove with reference to FIG. 2, the insulin infusion device 302 may beimplemented as a computer-based or processor-based components having thedescribed configuration and features, including the display element 212or other device-specific items 206 as described above.

The at least one controller 310 is configured and programmed to regulatethe operation of the fluid pump mechanism 328 and other functions of theinsulin infusion device 302. The at least one controller 310 controlsthe fluid pump mechanism 328 to deliver the fluid medication (e.g.,insulin) from the fluid reservoir 330 to the body 306. As mentionedabove, the at least one controller 310 can be housed in the infusiondevice housing, wherein the infusion communication system is anelectrical trace or a wire that carries the commands 320 from the atleast one controller 310 to the fluid pump mechanism 328. In alternativeembodiments, the at least one controller 310 can be housed in the sensorsystem housing, wherein the sensor communication system is an electricaltrace or a wire that carries the sensor signal 314 from the sensorelectrical components to the at least one controller 310. In accordancewith some embodiments, the at least one controller 310 has its ownhousing or is included in a supplemental or ancillary device. In otherembodiments, the at least one controller 310, the insulin infusiondevice 302, and the glucose sensor system 308 are all located within onecommon housing.

The sleep detection system 104 employs at least one sensor to obtaincorresponding user-specific sensor data (i.e., user status data). Theobtained user status data is processed or analyzed by the sleepdetection system 104 and/or by a suitably configured device or componentof the system 100 to determine whether the user is sleeping. Theobtained user status data may also be processed or analyzed to obtaincertain sleep-related parameters, characteristics, and/or metadata forthe user. For example, the obtained user status data may identify,include, or indicate any or all of the following, without limitation:timestamp data corresponding to when the user initially fell asleep;timestamp data corresponding to when the user wakes up; timestamp datacorresponding to periods of restless sleep; a sleep quality metric forthe user, which indicates how well the user slept for a given period oftime; a sleep duration metric for the user, which indicates how long theuser continuously slept; user posture or position information, whichindicates orientation of the user's body during sleep; body temperature;heartrate; blood pressure; respiratory rate; sweat level; eye or eyelidmovement, which may indicate periods of rapid eye movement sleep; eyelidposition (e.g., open or closed); images or video of the user; etc.

The sleep detection system 104 may include, cooperate with, or beimplemented as a gesture-based system, a motion-based system, anactivity-based system, a heartrate-based system, or the like. In certainembodiments, the sleep detection system 104 may be realized as a unitary“self-contained” wearable system that communicates with one or moreother components of the system 100. For example, the sleep detectionsystem 104 can be implemented with a wearable device such as an activitymonitor device, a smart watch device, a smart bracelet device, or thelike. In some embodiments, the sleep detection system 104 may berealized as a portable or wearable device that includes or communicateswith one or more external or ancillary sensor devices, units, orcomponents. For example, the sleep detection system 104 can beimplemented with a wearable or portable smart device that is linked withone or more external sensors worn or carried by the user. These andother possible deployments of the sleep detection system 104 arecontemplated by this disclosure. In this regard, United States patentpublication number US 2020/0135320 and U.S. patent application Ser. No.16/886,360 (filed May 28, 2020) disclose gesture-based physical behaviordetection systems that are suitable for use as the sleep detectionsystem 104; the entire content of these United States patent documentsis incorporated by reference herein.

FIG. 4 is a block diagram representation of a sleep detection system 400arranged in accordance with certain embodiments. The sleep detectionsystem 400 is suitable for use with the system 100 shown FIG. 1. Incertain embodiments, the sleep detection system 400 is deployed as awearable electronic device in the form factor of a bracelet or wristbandthat is worn around the wrist or arm of a user's dominant hand. Thesleep detection system 400 may optionally be implemented using a modulardesign, wherein individual modules include one or more subsets of thedisclosed components and overall functionality. The user may choose toadd specific modules based on personal preferences and requirements.

The sleep detection system 400 includes a battery 402 and a powermanagement unit (PMU) 404 to deliver power at the proper supply voltagelevels to all electronic circuits and components. The PMU 404 may alsoinclude battery-recharging circuitry. The PMU 404 may also includehardware, such as switches, that allows power to specific electronicscircuits and components to be cut off when not in use.

When there is no movement-based or gesture-based behavior event inprogress, most circuitry and components in the sleep detection system400 are switched off to conserve power. Only circuitry and componentsthat are required to detect or help predict the start of a behaviorevent of interest (such as sleeping or waking) may remain enabled. Forexample, if no motion is being detected, all sensor circuits but anaccelerometer 406 may be switched off and the accelerometer 406 may beput in a low-power wake-on-motion mode or in another lower power modethat consumes less power and uses less processing resources than itshigh performance active mode. A controller 408 of the sleep detectionsystem 400 may also be placed into a low-power mode to conserve power.When motion or a certain motion pattern is detected, the accelerometer406 and/or the controller 408 may switch into a higher power mode andadditional sensors such as, for example, a gyroscope 410 and/or aproximity sensor 412 may also be enabled. When a potential start of amovement-based or gesture-based event is detected, memory variables forstoring event-specific parameters, such as gesture types, gestureduration, etc. can be initialized.

In another example, upon detection of user motion, the accelerometer 406switches into a higher power mode, but other sensors remain switched offuntil the data from the accelerometer 406 indicates that the start of abehavior event has likely occurred. At that point in time, additionalsensors such as the gyroscope 410 and the proximity sensor 412 may beenabled.

In another example, when there is no behavior event in progress, boththe accelerometer 406 and gyroscope 410 are enabled but at least one ofeither the accelerometer 406 or the gyroscope 410 is placed in a lowerpower mode compared to their regular power mode. For example, thesampling rate may be reduced to conserve power. Similarly, the circuitryrequired to transfer data from the sleep detection system 400 to adestination device may be placed in a lower power mode. For example,radio circuitry 414 could be disabled. Similarly, the circuitry requiredto transfer data from the sleep detection system 400 may be placed in alower power mode. For example, the radio circuitry 414 could be disableduntil a possible or likely start of a behavior event has beendetermined. Alternatively, it may remain enabled but in a low powerstate to maintain the connection between the sleep detection system 400and one or more other components of the system 100, but withouttransferring user status data, sensor data, or the like.

In yet another example, all motion-detection related circuitry may beswitched off if, based on certain metadata, it is determined that theoccurrence of a particular behavior event, such as a food intake event,is unlikely. This may be desirable to further conserve power. Metadataused to make this determination may, among other things, include one ormore of the following: time of the day, location, ambient light levels,proximity sensing, and detection that the sleep detection system 400 hasbeen removed from the wrist or hand, detection that the sleep detectionsystem 400 is being charged, or the like. Metadata may be generated andcollected by the sleep detection system 400. Alternatively, metadata maybe collected by another device that is external to the sleep detectionsystem 400 and is configured to directly or indirectly exchangeinformation with the sleep detection system 400. It is also possiblethat some metadata is generated and collected by the sleep detectionsystem 400, while other metadata is generated and collected by a devicethat is external to the sleep detection system 400. In case some or allof the metadata is generated and collected external to the sleepdetection system 400, the sleep detection system 400 may periodically orfrom time to time power up its radio circuitry 414 to retrieve metadatarelated information from another device.

In certain embodiments, some or all of the sensors may be turned on orplaced in a higher power mode if certain metadata indicates that theoccurrence of a particular behavior event, such as the user fallingasleep, is likely. Metadata used to make this determination may, amongother things, include one or more of the following: time of the day;location; ambient light levels; proximity sensing; historical userbehavior patterns. Some or all of the metadata may be collected by sleepdetection system 400 or by an ancillary device that cooperates orcommunicates with the sleep detection system 400, as mentioned above.

User status data used to track certain aspects of a user's behavior maybe stored locally inside memory 416 of the sleep detection system 400and processed locally using the controller 408 of the sleep detectionsystem 400. User status data may also be transferred to the medicaldevice 102, the ancillary control system 108, and/or the ancillaryalerting device 110 (using, for example, the radio circuitry 414) forfurther processing and analysis. It is also possible that some of theprocessing and analysis are performed locally by the sleep detectionsystem 400, while further processing and analysis are performed by oneor more other components of the system 100.

The detection of the start of a behavior event, such as the start of asleeping period, may trigger the power up and/or activation ofadditional sensors and circuitry, such as a camera module 418. Power upand/or activation of additional sensors and circuitry may occur at thesame time as the detection of the behavior event of interest or sometime thereafter. Specific sensors and circuitry may be turned on only atspecific times during a detected event, and may be switched offotherwise to conserve power. It is also possible that the camera module418 only gets powered up or activated upon explicit user interventionsuch as, for example, pushing and holding a button 420. Releasing thebutton 420 may turn off the camera module 418 to conserve power.

When the camera module 418 is powered up, a projecting light source 422may also be enabled to provide visual feedback to the user about thearea that is within view of the camera or to otherwise illuminate thefield of view. Alternatively, the projecting light source 422 may onlybe activated sometime after the camera module 418 has been activated. Incertain cases, additional conditions may need to be met before theprojecting light source 422 is activated. Such conditions may include:the determination that the projecting light source 422 is likely aimingin the direction of the object of interest; the determination that thesleep detection system 400 is not moving excessively; or the like. Insome embodiments, one or more light emitting diodes (LEDs) 426 may beused as the projecting light source 422.

Images may be tagged with additional information or metadata such as:camera focal information; proximity information from the proximitysensor 412; ambient light levels information from an ambient lightsensor 424; timestamp information; etc. Such additional information ormetadata may be used during the processing and analysis of the userstatus data.

The projecting light source 422 may also be used to communicate otherinformation. As an example, an ancillary device may use inputs from oneor more proximity sensors 412, process those inputs to determine if thecamera module 418 is within the proper distance range from the object ofinterest, and use one or more light sources to communicate that thecamera is within the proper distance range, that the user needs toincrease the distance between camera and the object of interest, or thatthe user needs to reduce the distance between the camera and the objectof interest.

The projecting light source 422 may also be used in combination with theambient light sensor 424 to communicate to the user if the ambient lightis insufficient or too strong for an adequate quality image capture. Theprojecting light source 422 may also be used to communicate informationincluding, but not limited to, a low battery situation or a functionaldefect.

The projecting light source 422 may also be used to communicate dietarycoaching information. As an example, the projecting light source 422might, among other things, indicate if not enough or too much time hasexpired since a previous food intake event, or may communicate to theuser how he/she is doing against specific dietary goals.

Signaling mechanisms to convey specific messages using one or moreprojecting light sources 422 may include, but are not limited to, one ormore of the following: specific light intensities or light intensitypatterns; specific light colors or light color patterns; specificspatial or temporal light patterns. Multiple mechanisms may also becombined to signal one specific message.

A microphone 428 may be used by the user to add specific or customlabels or messages to a detected event and/or image. Audio snippets maybe processed by a voice recognition engine.

In certain embodiments, the accelerometer 406 (possibly combined withother sensors, including other inertial sensors) may, in addition totracking at least one parameter that is directly related to agesture-based behavior event, also be used to track one or moreparameters that are not directly related to that particular event. Suchparameters may, among other things, include physical activity, sleep,eating, or stress.

In addition to the particular sensors, detectors, and componentsmentioned above, the sleep detection system 400 may include or cooperatewith any number of other sensors 430 as appropriate for the particularembodiment. The sleep detection system 400 obtains user status data fromone or more of its sensors, detectors, and sources, wherein the userstatus data indicates sleeping status of the user. The user status datacan be analyzed and processed by the sleep detection system 400 (and/orby one or more other components of the system 100) to determine whetherthe user is sleeping and, in certain embodiments, to determineadditional information, characteristics, or metrics related to theuser's sleeping status. In certain embodiments, the sleep detectionsystem 400 and/or an ancillary system or device determines the user'ssleeping status primarily based on the output of user-worn motionsensors, movement sensors, one or more inertial sensors (e.g., one ormore accelerometers and/or one or more gyroscopes), one or more GPSsensors, one or more magnetometers, one or more force or physicalpressure sensors, or the like, which are suitably configured,positioned, and arranged to measure physical movement or motion of theuser's limbs, digits, joints, facial features, head, and/or other bodyparts.

In some embodiments, the sleep detection system 400 includes at leastone haptic interface 440 that is suitably configured and operated toprovide haptic feedback as an output. The at least one haptic interface440 generates output(s) that can be experienced by the sense of touch bythe user, e.g., mechanical force, vibration, movement, temperaturechanges, or the like. Haptic feedback generated by the at least onehaptic interface 440 may represent or be associated with one or more ofthe following, without limitation: reminders; alerts; confirmations;notifications; messages; numerical values (such as measurements); statusindicators; or any other type of output provided by the sleep detectionsystem 400.

In certain embodiments, the user status data (e.g., sensor data) isprovided to a gesture recognizer unit or processing module. To this end,sensor data may be sent in raw format. Alternatively, a source of sensordata may perform some processing (e.g., filtering, compression, orformatting) on raw sensor data before sending the processed sensor datato the gesture recognizer unit. The gesture recognizer unit analyzes theincoming sensor data and converts the incoming sensor data into a streamof corresponding gestures, which may be predetermined or otherwiseclassified or categorized. The gesture recognizer unit may use one ormore ancillary inputs to aid in the gesture determination process.Nonlimiting examples of an ancillary input include: time of day; theprobability of a specific gesture occurring based on statisticalanalysis of historical gesture data for that user; geographicallocation; heart rate; other physiological sensor inputs. Other ancillaryinputs are also possible.

The output of the gesture recognizer unit—the detected gestures—can besent to an event detector or processing module. The event detectoranalyzes the incoming stream of gestures to determine if the start of anevent of interest (e.g., sleep) has occurred, whether an event isongoing, whether an event has ended, or the like. For example, if theevent detector is implemented as a sleep detector intended to capturesleeping/waking events, it will be suitably configured to determine ifthe start of a sleeping period has occurred, if the user is stillsleeping, or if the user is awake. Although this description focuses onsleep detection, a gesture-based physical behavior detection system maybe suitably configured to monitor other types of physical behavior oractivities. Such activities include, without limitation: reading;drinking; smoking; getting dressed; turning down a bed; making a bed;brushing teeth; combing hair; talking on the phone; inhaling orinjecting a medication; and activities related to hand hygiene orpersonal hygiene.

Referring again to FIG. 1, certain functions, features, and/or therapyrelated operations of the medical device 102 can be adjusted or modifiedin response to the output of the sleep detection system 104. Morespecifically, operation of the medical device 102 can be controlled orregulated based on a determination that the user is sleeping. Forexample, if the system 100 determines that the user is sleeping, a sleepmode alerting scheme of the medical device 102 can be activated (insteadof a default alerting scheme). As another example, if the system 100determines that the user is sleeping, then a target glucose setpointvalue (utilized by an insulin infusion device during an automaticinsulin delivery mode) can be temporarily lowered.

FIG. 5 is a flow chart that illustrates an alert control process 500according to certain embodiments. The process 500 represents anautomated method of controlling alerts associated with the operation ofa medical device, such as an insulin infusion device. The process 500receives user status data (e.g., sleep status data) that indicates thesleeping status of a user of the medical device (task 502). As mentionedabove, the user status data is generated by sensors, detector units, orother sources of data that are included with or associated with asuitably configured sleep detection system (e.g., the analyte sensor106, the accelerometer 406, the gyroscope 410, the proximity sensor 412,one or more other sensors 430, the microphone 428, and/or the cameramodule 418). Depending on the particular embodiment, task 502 may beperformed by the sleep detection system and/or by an ancillary system ordevice other than the sleep detection system. The process 500 continuesby analyzing or processing at least some of the received user statusdata to determine whether the user is sleeping (query task 504). Ifanalysis of the user status data indicates that the user is sleeping(the “Yes” branch of query task 504), then the process 500 activates asleep mode alerting scheme for the medical device (task 506). The sleepmode alerting scheme replaces, supplements, or modifies the existingalerting scheme (which may be a default, baseline, or standard alertingscheme utilized by the medical device, i.e., an unmodified scheme thatis utilized during normally expected operation of the medical devicewhile the user is awake). If analysis of the user status data indicatesthat the user is not asleep (the “No” branch of query task 504), thenthe process maintains and utilizes the currently active alerting schemeof the medical device, e.g., the default, baseline, or standard alertingscheme (task 508). After activating the sleep mode alerting scheme, theprocess 500 continues by controlling the generation and outputting ofalerts associated with the operation of the medical device (task 510),wherein the generation and outputting of alerts are performed inaccordance with the activated sleep mode alerting scheme.

In certain embodiments, the sleep mode alerting scheme silences (e.g.,inhibits the generation or outputting, or generates but mutes),temporarily disables, or delays the outputting of at least one alertwhile the user is asleep. The sleep mode alerting scheme may queue atleast one alert for subsequent presentation or outputting to the user ina first-in, first-out order or a rearranged order that may be influencedby a priority assigned to the alerts, the importance of the alerts, orany other criteria. In this regard, the process 500 can delay or queuean alert such that it does not wake up the user, but is displayed,output, or otherwise presented after the user wakes up. The user can benotified of any delayed or queued alerts, and reminded or prompted toview and clear such alerts. Delayed or queued alerts may be identifiedin a selectable list that allows the user to choose which alerts toview, and in which order. The user may be required to view and clearsome alerts to silence an ongoing alert or to prevent repeatednotifications or reminders. In some embodiments, delayed or queuedalerts may be displayed in one or more windows or in one or moremessages in succession or concurrently, and displayed messages/windowsmay be accompanied by audible alert sounds and/or haptic feedbackintended to notify the user or otherwise obtain the attention of theuser. It should be appreciated that the specific manner in whichdelayed, silenced, or queued alerts/messages are subsequently presentedto the user may vary, depending on the particular implementation, theintended application of the medical device, user preferences orsettings, healthcare provider preferences or settings, or the like.

In accordance with some embodiments, the sleep mode alerting schemechanges a default output type, mode, or source (for at least one alert)to an elevated output type, mode, or source that is more aggressive thanthe default output type, for example, an output type that is unmodified,unrestricted, or is normally utilized by the device during waking hours.As used here, an alert that is “more aggressive” than its defaultcounterpart is louder, more noticeable, more recognizable, more frequentor repetitive, stronger, or otherwise designed to wake up a sleepinguser. For example, the default output type may be associated withoutputting of an alert by a default alerting device, such as the medicaldevice itself. In contrast, the elevated output type may be associatedwith outputting of an alert by an ancillary alerting device that isdifferent than the default alerting device, such as an alarm clock, theuser's mobile phone, a security system alarm unit, the user'ssmart-watch, or the like. Different annunciation/output types include,without limitation: audible alarms, alerts, or messages; hapticfeedback, such as vibration of a device in the system; visible alarms,alerts, or messages, such as flashing lights, a pattern of lights, orillumination of a display screen; and displayable alarms, alerts, ormessages. In certain embodiments, the elevated output type can beutilized in concert with, or in lieu of, the default output type.Accordingly, the sleep mode alerting scheme can utilize the elevatedoutput types, modes, or sources for important, critical, time sensitive,and/or safety-related alerts that occur when the user is sleeping.

The medical device 102 can generate any number of alerts, notifications,messages, reminders, or the like (collectively referred to herein as“alerts”). The alerts can be ranked or prioritized in the context of thedefault alerting scheme and/or in the context of the sleep mode alertingscheme. At least some alerts can be reprioritized for the sleep modealerting scheme. Alerts may be related to status of the medical device102 (e.g., battery status), status of disposables or consumables used bythe medical device 102 (e.g., insulin reservoir level), user/patientstatus, therapy delivery, calendar entries, or the like. Alerts can beprioritized based on their relationship or association with patientsafety, operating health of the medical device 102, or the like. Forexample, routine reminders or notifications that are unrelated totherapy or patient health might be deemed “low priority” and, therefore,silenced while the user is sleeping. As another example, important orurgent alerts that relate to patient safety or critical functions or themedical device 102 may be deemed “high priority” and, therefore, keptactive while the user is sleeping.

In some embodiments, the user status data provided by the sleepdetection system 104 includes a sleep quality metric that measures,quantifies, or otherwise indicates how well the user has slept or howwell the user is sleeping. For example, the sleep quality metric may bebased on any or all of the following data, without limitation: heartrate; respiratory rate; amount of movement (tossing and turning) duringsleep; eye movement; snoring sounds; etc. The sleep quality metricgenerated by the sleep detection system 104 can be used to regulate oradjust the sleep mode alerting scheme. More specifically, the sleep modealerting scheme can be designed such that it regulates the generation oroutputting of alerts as a function of the sleep quality metric generatedby the sleep detection system. Thus, if the sleep quality metricindicates that the user has been sleeping well (e.g., in deep sleep orREM sleep), then the sleep mode alerting scheme can be adjusted toaccommodate that sleeping state. If the sleep quality metric indicatesthat the user has not been sleeping well or is in a state of shallow orgentle sleep, then the sleep mode alerting scheme can be adjusted in amanner that assumes that the user is not actually sleeping, yet notfully awake. Accordingly, the manner in which different alerts arehandled (e.g., silenced, delayed, deleted, queued, repeated) and/or themanner in which different alerts are annunciated or output (e.g., usingthe native functionality of the medical device 102, using an escalatedor elevated output scheme, and/or using one or more ancillary alertingdevices 110) can vary in response to the current value of the sleepquality metric.

In some embodiments, the user status data provided by the sleepdetection system 104 includes a sleep duration metric that measures,quantifies, or otherwise indicates how long the user slept or how longthe user has been sleeping. For example, the sleep duration metric maybe a time value based on when the sleep detection system 104 determinedthat the user fell asleep. The sleep duration metric generated by thesleep detection system 104 can be used to regulate or adjust the sleepmode alerting scheme. More specifically, the sleep mode alerting schemecan be designed such that it regulates the generation or outputting ofalerts as a function of the sleep duration metric generated by the sleepdetection system. Thus, if the sleep duration metric indicates that theuser has been continuously sleeping for an extended period of time(e.g., more than two hours), then the sleep mode alerting scheme can beadjusted to accommodate that sleeping state. If the sleep durationmetric indicates that the user has only been sleeping for a few minutes,then the sleep mode alerting scheme can be adjusted in a manner thatassumes that the user is not actually sleeping, yet not fully awake.Accordingly, the manner in which different alerts are handled (e.g.,silenced, delayed, deleted, queued, repeated) and/or the manner in whichdifferent alerts are annunciated/output (e.g., using the nativefunctionality of the medical device 102, using an escalated or elevatedoutput scheme, and/or using one or more ancillary alerting devices 110)can vary in response to the current value of the sleep duration metric.

As one non-limiting example, a “Low Glucose” alert can be elevated to ahigher priority during sleep. Moreover, the output characteristics of a“Low Glucose” alert can change in a dynamic manner if the user does notrespond during sleep. As another non-limiting example, an “Occlusion”alarm (which may be utilized by a fluid infusion system) can be elevatedto a higher priority during sleep, and its output characteristics canescalate in a dynamic manner if the user does not respond during sleep.As another non-limiting example, a “Low Reservoir” alert can besuppressed or given a lower priority during sleeping periods if theremaining operating time (or amount of fluid remaining in the reservoir)allows the alert to be addressed after the user's regular wake-up time.As another non-limiting example, a “Low Battery” alert can besuppressed, delayed, or given a lower priority during sleeping periodsif the remaining battery time allows the alert to be addressed after theuser wakes up. As another non-limiting example, a “High Glucose” alertcan remain unchanged (i.e., its priority is not changed and its outputcharacteristics remain the same) during periods of sleep.

FIG. 6 is a flow chart that illustrates an alert annunciation/outputcontrol process 600 according to certain embodiments. The process 600may be performed in conjunction with the process 500 described above.Indeed, this description assumes that the process 600 is performed afterthe system 100 has determined that the user is sleeping. The process 600outputs a safety alert using a default output type (task 602), andchecks whether the safety alert has been ignored or attended to (querytask 604). As used here, a safety alert is any alert that relates to,indicates, or is otherwise associated with a condition, a device state,user status, system state, or environmental condition that implicatesthe health, well-being, quality of life, or security of the user. Inthis regard, safety alerts can be distinguished from non-criticalalerts, routine reminders, and unimportant messages that have little tono impact on patient health or therapy outcomes and, therefore, can besafely and confidently delayed, ignored, deleted, or disregarded duringperiods of sleep.

If the user responds to the safety alert or if the safety alert isotherwise attended to (the “No” branch of query task 604), then theprocess 600 exits and the system 100 handles the safety alert in anappropriate manner. If the process 600 confirms that the safety alerthas been ignored for at least a threshold period of time (the “Yes”branch of query task 604), then the process 600 continues by takingappropriate action that is intended to notify or wake up the user. Incertain embodiments, the process 600 continues by changing the defaultoutput type to an elevated output type that is more aggressive than thedefault output type (task 606), as described above. Next, the process600 re-outputs the safety alert using the elevated output type (task608). If the user continues to ignore the safety alert, then task 606and task 608 can be repeated to continue escalating or modifying theoutput type, mode, or source in an appropriate manner. Thus, additional,different, louder, longer duration, more prevalent, more frequent, ormore repetitive alerts or alarms can be used to escalate the manner inwhich the safety alert is output in an ongoing manner, in an attempt toawaken the user.

Referring again to FIG. 5, in certain implementations, the medicaldevice 102 receives the user status data, processes the user status datato determine whether the user is sleeping, and activates a native sleepmode alerting scheme. In some embodiments, at least one ancillarycontrol system 108 and/or at least one ancillary alerting device 110receives the user status data, processes the user status data todetermine whether the user is sleeping, and activates or controls asleep mode alerting scheme for the medical device 102. In suchembodiments, the native alerting functionality of the medical device 102can be remotely controlled and/or an ancillary alerting device 110 canbe controlled to execute the sleep mode alerting scheme. As mentionedabove, controllers resident at the different components of the system100 can be suitably configured and programmed to perform the methods andprocesses described here, individually or in a distributed or collectivemanner.

FIG. 7 is a flow chart that illustrates an insulin infusion devicecontrol process 700 according to certain embodiments. A number ofcurrently available hybrid closed-loop insulin delivery systems useglucose sensor feedback control algorithms to regulate the user's bloodglucose to a fixed “factory setting” setpoint, such as 120 mg/dL or 100mg/dL. A fixed setpoint at or near 120 mg/dL represents a good targetglucose for the vast majority of users that balances effective long termblood sugar control with safety (with respect to hypoglycemia). However,many users may desire a higher or lower setpoint to suit theirindividual needs. Disclosed here is an insulin infusion system thataccommodates a variable target glucose setpoint, which can be adjustedin response to the detected sleeping status of the user. The adjustableglucose setpoint can be programmable to move to different levels atdifferent times, such as a lower setpoint during sleeping periods togive a low fasting glucose, and a higher setpoint when the user isawake.

The process 700 represents an automated method of operating a medicaldevice, such as the insulin infusion device 302 depicted in FIG. 3. Thisdescription assumes that the insulin infusion device is operating in anautomatic mode to automatically control delivery of insulin to the user(task 702). As explained above with reference to FIG. 3, insulindelivery is controlled and regulated in accordance with various factors,sensor data, user-specific settings, etc., including a first or defaulttarget glucose setpoint value. The first target glucose setpoint valuemay be user-configurable, fixed by the manufacturer of the insulininfusion device, set by the user's physician or caregiver, or the like.In certain embodiments, the first target glucose setpoint value ischosen to be 120 mg/dL, although other values can be used.

The process 700 receives user status data (e.g., sleep status data) thatindicates the sleeping status of a user of the medical device (task 704)and analyzes or processes at least some of the received user status datato determine whether the user is sleeping (query task 706). Task 704 issimilar to task 502 of the process 500, and query task 706 is similar toquery task 504 of the process 500, as described above with reference toFIG. 5. If analysis of the user status data indicates that the user isawake, then the process 700 maintains the first target glucose setpointvalue as the currently active or applicable value for regulating thedelivery of insulin during the automatic delivery mode (task 708).Accordingly, FIG. 7 depicts the process 700 leading back to task 702 forcontinued operation of the insulin infusion device.

This example assumes that the process 700 determines, from the userstatus data, that the user is sleeping while the insulin infusion deviceis operating in the automatic mode. In response to the determinationthat the user is sleeping, the process 700 adjusts the target glucosesetpoint value by automatically transitioning (without user input) fromthe first target glucose setpoint value to a second target glucosesetpoint value, different than the first target glucose setpoint value,for use during the automatic mode (task 710). In some examples, thesecond target glucose setpoint value is higher than the target glucosesetpoint value. In some examples, the second target glucose setpointvalue is lower than the target glucose setpoint value. The process 700continues to operate the insulin infusion device in the automatic modeto automatically control the delivery of insulin to the user, inaccordance with the second target glucose setpoint value (task 712). Insome embodiments, the process 700 monitors the sleep duration of theuser and initiates the transitioning to the second target glucosesetpoint value when the sleep duration exceeds a threshold time period(e.g., 30 minutes, 1 hour, 2 hours, or any other period of time). Inother words, adjusting the target glucose setpoint value may occur assoon as the user falls asleep, or it may be delayed until the process700 confirms that the user has been sleeping for at least the thresholdtime period. In some embodiments, in addition to the duration of thesleep, the user's glucose condition can be considered. For example, ifthe duration of sleep is longer than the threshold time period andsensor glucose measurements are stable around the first target glucosesetpoint value, then the process 700 can proceed and transition (withoutuser input) to the second target glucose setpoint value. In someembodiments, the process 700 considers an estimated amount of plasmainsulin for the user as a factor that influences whether to transitionwithout user input to the second target glucose setpoint value. Otherfactors, parameters, and data that can be considered before adjustingthe target glucose setpoint value include, without limitation: sensorglucose data availability; current or historical sensor glucose levels;and/or the rate of change of sensor glucose readings.

FIG. 7 shows the process 700 leading back to task 704 to receive updatedor additional user status data for continued monitoring and processingduring the automatic mode. If the process 700 determines (from theadditional user status data) that the user is no longer sleeping, thentask 708 can transition, without user input, from the second targetglucose setpoint value to the first target glucose setpoint value, or toanother target glucose setpoint value that is appropriate for thecurrent user state. Thereafter, the process 700 continues to operate theinsulin infusion device in the automatic mode, using the first targetglucose setpoint value as a reference. If the user remains asleep, thenthe second target glucose setpoint value is maintained for ongoing useduring the automatic mode (task 710).

Transitioning from one target glucose setpoint value to another withoutuser input may be performed gradually or continuously over apredetermined period of time, e.g., 30 minutes, an hour, or the like.Transitioning over time in this manner assumes that the user remainsasleep before and during the transition period. In certain embodiments,transitioning from one target glucose setpoint value to another withoutuser input is performed quickly or immediately following the detectionof a sleeping state. In other words, the process 700 can simply switchfrom one setpoint value to another in a stepwise manner.

For the example described here, the second target glucose setpoint valueis lower than the first (default) target glucose setpoint value.Lowering the setpoint value is appropriate during sleeping hours becausethe automatic control algorithm need not consider additional factorssuch as eating, exercise, heartrate variations, etc. As an example, thefirst value may be 120 mg/dL and the second value may be 100 mg/dL, 80mg/dL, or any value that is safe and appropriate for the particularuser. The second target glucose setpoint value may be a fixed value thatis set by the manufacturer of the insulin infusion device, the user, acaregiver, etc. In some embodiments, the second target glucose setpointvalue is higher than the first target glucose setpoint value. As anexample, the first value may be 120 mg/dL and the second value may be130 mg/dL or any value that is safe and appropriate for the particularuser.

In certain embodiments, the second target glucose setpoint value can bevariable or dynamic in nature to respond to the particular sleepingstatus, the current user condition or glucose state, or the like. Forexample, the user status data provided by the sleep detection system 104may include a sleep quality metric (as described above with reference tothe process 500). The sleep quality metric generated by the sleepdetection system 104 can be used to regulate or adjust the currentlyactive second target glucose setpoint value without user input. Morespecifically, the second target glucose setpoint value can be adjustedas a function of the sleep quality metric generated by the sleepdetection system. For example, the adjustment amount and/or theadjustment time period may be influenced by the sleep quality metric. Inthis regard, the target glucose setpoint value can be regulated as afunction of sleep quality by monitoring non-diabetic individual(s) andmimicking the manner in which a non-diabetic person regulates glucose.Thus, physiological data, sleep-related data, and glucose responsecharacteristics associated with non-diabetic individuals can be utilizedto automatically adjust the target glucose setpoint value for diabeticusers, as a function of sleep quality.

In some embodiments, the user status data provided by the sleepdetection system 104 includes a sleep duration metric (as describedabove with reference to the process 500). The sleep duration metricgenerated by the sleep detection system 104 can be used to regulate oradjust the currently active second target glucose setpoint value withoutuser input. More specifically, the target glucose setpoint value can beautomatically adjusted as a function of the sleep duration metricgenerated by the sleep detection system. Thus, the adjustment amountand/or the adjustment time period may be influenced by the sleepduration metric. For example, if the user has only been sleeping for onehour, then the setpoint value may be adjusted by only an initial amount.If, however, the sleep duration metric indicates that the user has beencontinuously sleeping for an extended period of time (e.g., more thantwo hours or any other period of time), then it may be appropriate tolower the target glucose setpoint value by an additional amount.

As explained above, the target glucose setpoint value represents asetting, parameter, or variable of the insulin delivery controlalgorithm, which can be adjusted or regulated, without user input, as afunction of sleep detection and/or certain sleep-relatedcharacteristics. In accordance with certain embodiments, one or moreadditional or alternative settings, parameters, or variables can beadjusted based on sleep detection. For example, controller gain values(which are utilized by the automatic insulin delivery control algorithm)can be adjusted as a function of sleep detection and/or certainsleep-related characteristics. In certain embodiments, the controller ofan insulin infusion device employs a proportional-integral-derivativeinsulin feedback (PID-IFB) control algorithm designed for continuousclosed-loop insulin delivery control. Some implementations of thePID-IFB control algorithm include PID gain values that are applied to anerror term, a time derivative of sensor glucose term, and an integralerror term (which is the integral action on historical errors betweensensor glucose readings and the controller setpoint, such as 100 mg/dL).Moreover, certain implementations of the PID-IFB control algorithmcalculate the IFB using time constants that can be adjusted based onsleep detection or observed/measured sleeping characteristics. Inaddition, certain implementations of the PID-IFB control algorithmemploy a maximum insulin limit (referred to as “Umax”) that governs theinsulin dosage output of the control algorithm—Umax can also be adjustedbased on sleep detection or observed/measured sleeping characteristics.In this regard, the controller gain values, Umax, and/or time constantscan be regulated to make the controller more or less responsive tochanges in sensor glucose measurements during sleeping periods.

Referring again to FIG. 5, in certain implementations, the medicaldevice 102 receives the user status data, processes the user status datato determine whether the user is sleeping, and adjusts the targetglucose setpoint value as needed. In some embodiments, at least oneancillary control system 108 receives the user status data, processesthe user status data to determine whether the user is sleeping, andremotely controls the medical device 102 (as needed) to cause theadjustment of the target glucose setpoint value. For example, theancillary control system 108 can generate and send commands,instructions, and/or control signals to the medical device 102, whereinthe commands, instructions, and/or control signals cause the medicaldevice 102 (e.g., the insulin infusion device) to transition from onetarget glucose setpoint value to another without user input. In suchembodiments, the native insulin delivery control scheme of the insulininfusion device can be remotely controlled to respond to the sleepingstatus of the user. As mentioned above, controllers resident at thedifferent components of the system 100 can be suitably configured andprogrammed to perform the methods and processes described here,individually or in a distributed or collective manner.

The various tasks performed in connection with a process disclosedherein may be performed by software, hardware, firmware, or anycombination thereof. It should be appreciated that an embodiment of anillustrated process may include any number of additional or alternativetasks, the tasks shown in the figures need not be performed in theillustrated order, and a disclosed process may be incorporated into amore comprehensive procedure or process having additional functionalitynot described in detail herein. Moreover, one or more of the tasks shownin a figure could be omitted from an embodiment of the depicted processas long as the intended overall functionality remains intact.

While at least one exemplary embodiment has been presented in theforegoing detailed description, it should be appreciated that a vastnumber of variations exist. It should also be appreciated that theexemplary embodiment or embodiments described herein are not intended tolimit the scope, applicability, or configuration of the claimed subjectmatter in any way. Rather, the foregoing detailed description willprovide those skilled in the art with a convenient road map forimplementing the described embodiment or embodiments. It should beunderstood that various changes can be made in the function andarrangement of elements without departing from the scope defined by theclaims, which includes known equivalents and foreseeable equivalents atthe time of filing this patent application.

What is claimed is:
 1. A method of operating an insulin infusion devicecomprising a fluid pump mechanism and at least one controller thatregulates operation of the fluid pump mechanism to deliver insulin fromthe insulin infusion device, the method comprising: operating theinsulin infusion device in an automatic mode to automatically controldelivery of insulin to a user, in accordance with a first target glucosesetpoint value; receiving user status data that indicates sleepingstatus of the user, the user status data generated by a sleep detectionsystem; determining, from the user status data, that the user issleeping while the insulin infusion device is operating in the automaticmode; in response to the determining, transitioning from the firsttarget glucose setpoint value to a second target glucose setpoint valuefor use during the automatic mode, the transitioning occurring withoutuser input, and the second target glucose setpoint value different thanthe first target glucose setpoint value; and continuing to operate theinsulin infusion device in the automatic mode to automatically controldelivery of insulin to the user, in accordance with the second targetglucose setpoint value.
 2. The method of claim 1, wherein the secondtarget glucose setpoint value is lower than the first target glucosesetpoint value.
 3. The method of claim 1, further comprising: receivingadditional user status data that indicates sleeping status of the user,the additional user status data generated by the sleep detection system;determining, from the additional user status data, that the user isawake; in response to determining that the user is awake, transitioningfrom the second target glucose setpoint value to the first targetglucose setpoint value without user input; and continuing to operate theinsulin infusion device in the automatic mode to automatically controldelivery of insulin to the user, in accordance with the first targetglucose setpoint value.
 4. The method of claim 1, wherein: the userstatus data includes a sleep quality metric for the user, the sleepquality metric generated by the sleep detection system; and thetransitioning step adjusts the first target glucose setpoint value as afunction of the sleep quality metric to obtain the second target glucosesetpoint value.
 5. The method of claim 1, wherein: the user status dataincludes a sleep duration metric for the user, the sleep duration metricgenerated by the sleep detection system; and the transitioning stepadjusts the first target glucose setpoint value as a function of thesleep duration metric to obtain the second target glucose setpointvalue.
 6. The method of claim 1, wherein: the sleep detection system isseparate and distinct from the insulin infusion device; and the insulininfusion device performs the receiving, determining, and transitioningsteps.
 7. The method of claim 1, wherein: the insulin infusion devicecomprises the sleep detection system; and the insulin infusion deviceperforms the receiving, determining, and transitioning steps.
 8. Themethod of claim 1, wherein: the receiving and determining steps areperformed by an ancillary control system that communicates with theinsulin infusion device; and the ancillary control system sends at leastone command to the insulin infusion device, the at least one commandcausing the insulin infusion device to perform the transitioning step.9. The method of claim 1, wherein the transitioning step graduallyadjusts the first target glucose setpoint value to the second targetglucose setpoint value over a predetermined period of time.
 10. Themethod of claim 1, further comprising: monitoring a sleep duration ofthe user; and initiating the transitioning when the sleep durationexceeds a threshold time period.
 11. An insulin infusion devicecomprising: a fluid pump mechanism; at least one controller thatregulates operation of the fluid pump mechanism to deliver insulin fromthe insulin infusion device; and at least one memory element associatedwith the at least one controller, the at least one memory elementstoring processor-executable instructions configurable to be executed bythe at least one controller to perform a method of controlling operationof the insulin infusion device, the method comprising: operating theinsulin infusion device in an automatic mode to automatically controldelivery of insulin to a user, in accordance with a first target glucosesetpoint value; receiving user status data that indicates sleepingstatus of the user, the user status data generated by a sleep detectionsystem; determining, from the user status data, that the user issleeping while the insulin infusion device is operating in the automaticmode; in response to the determining, transitioning from the firsttarget glucose setpoint value to a second target glucose setpoint valuefor use during the automatic mode, the transitioning occurring withoutuser input, and the second target glucose setpoint value different thanthe first target glucose setpoint value; and continuing to operate theinsulin infusion device in the automatic mode to automatically controldelivery of insulin to the user, in accordance with the second targetglucose setpoint value.
 12. The insulin infusion device of claim 11,wherein the insulin infusion device receives the user status datadirectly from the sleep detection system.
 13. The insulin infusiondevice of claim 11, wherein the method performed by the at least onecontroller further comprises: receiving additional user status data thatindicates sleeping status of the user, the additional user status datagenerated by the sleep detection system; determining, from theadditional user status data, that the user is awake; in response todetermining that the user is awake, transitioning from the second targetglucose setpoint value to the first target glucose setpoint valuewithout user input; and continuing to operate the insulin infusiondevice in the automatic mode to automatically control delivery ofinsulin to the user, in accordance with the first target glucosesetpoint value.
 14. The insulin infusion device of claim 11, wherein:the user status data includes a sleep quality metric for the user, thesleep quality metric generated by the sleep detection system; and thetransitioning step adjusts the first target glucose setpoint value as afunction of the sleep quality metric to obtain the second target glucosesetpoint value.
 15. The insulin infusion device of claim 11, wherein:the user status data includes a sleep duration metric for the user, thesleep duration metric generated by the sleep detection system; and thetransitioning step adjusts the first target glucose setpoint value as afunction of the sleep duration metric to obtain the second targetglucose setpoint value.
 16. The insulin infusion device of claim 11,wherein the transitioning step gradually adjusts the first targetglucose setpoint value to the second target glucose setpoint value overa predetermined period of time.
 17. The insulin infusion device of claim11, wherein the method performed by the at least one controller furthercomprises: monitoring a sleep duration of the user; and initiating thetransitioning when the sleep duration exceeds a threshold time period.18. A system comprising: an insulin infusion device that regulatesdelivery of insulin to a user; a sleep detection system configured togenerate user status data that indicates sleeping status of a user, andconfigured to communicate the user status data; and at least onecontroller that controls operation of the insulin infusion device, theat least one controller configured to: operate the insulin infusiondevice in an automatic mode to automatically control delivery of insulinto a user, in accordance with a first target glucose setpoint value;receive the user status data generated by the sleep detection system;determine, from the user status data, that the user is sleeping whilethe insulin infusion device is operating in the automatic mode; inresponse to determining that the user is sleeping, transition from thefirst target glucose setpoint value to a second target glucose setpointvalue for use during the automatic mode, the transitioning occurringwithout user input, and the second target glucose setpoint valuedifferent than the first target glucose setpoint value; and continue tooperate the insulin infusion device in the automatic mode toautomatically control delivery of insulin to the user, in accordancewith the second target glucose setpoint value.
 19. The system of claim18, wherein the insulin infusion device comprises the at least onecontroller.
 20. The system of claim 18, wherein the sleep detectionsystem comprises a gesture-based, motion-based, or activity-baseddetection system.
 21. The system of claim 18, wherein the medical devicecomprises the sleep detection system.